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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04769843
Other study ID # 1508794
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 24, 2021
Est. completion date December 31, 2021

Study information

Verified date January 2022
Source Northern Arizona University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this online study, investigators will explore the psychosocial burdens of swallowing difficulties in people with Parkinson's Disease. This study is completely virtual, so you can participate from wherever you live in the United States. Participation requires you to complete a one-hour Zoom interview and a brief questionnaire. You will be compensated with a $25 Walmart gift card. To learn more, please use the "send email" feature. Thank you!


Description:

This is a mixed methods study. The investigators will collect qualitative data from participants by conducting 1-2 hour semi-structured interviews on Zoom. The interview questions are designed to systemically inquire about patient experiences, affective reactions, coping strategies, social support, self-identity issues, and treatment experiences. The investigators will collect quantitative data by asking participants to complete The Brief Illness Perception Questionnaire. The data will be analyzed using a comprehensive stress and coping model, which has not been done previously in the field. The investigators hope to discover themes about psychosocial burdens and related coping mechanisms.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Participants must currently have oropharyngeal dysphagia and Parkinson Disease - Participants must be at least 18 years of age - Participants must speak English. Exclusion Criteria: - Participants whose receptive and expressive language skills will not allow them to participate in one-on-one interviews

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Northern Arizona University Flagstaff Arizona

Sponsors (1)

Lead Sponsor Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of the Impact of Swallowing Impairment on Individuals with Parkinson Disease as Expressed During Interviews A 1-2 hour, semi-structured interview will be conducted with each participant on Zoom to identify patient experiences, affective reactions, coping strategies, social support, self-identity issues, and treatment experiences associated with swallowing impairment. To be assessed from the participant interviews through study completion, an average of 1 year.
Secondary Overall Score on Brief Illness Perception Questionnaire (Brief IPQ) as Self-Reported by Participants The Brief IPQ is a self-report survey that contains nine items that quantify the cognitive and emotional representations of an illness. It has good test-retest reliability and concurrent validity with relevant measures in a few populations with chronic disease. Scores range from 0 (i.e., illness has no effect on life) to 80 points (i.e., illness extremely effects various aspects of life). The Brief IPQ will be mailed to participants after their interview and asked to complete it and return it to us within one week.
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